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Document Workshops

Regardless of sector, size, structure, or maturity, regulated organizations must establish an appropriate quality management system (QMS) to be successful. The most important aspect of any QMS is the way in which it is documented to manifest the system hierarchy. The two-day document workshop, delivered on-site at the customer's facility of choice, explores the process model approach for the creation and operation of an effectively documented QMS - one that complies with FDA, ISO, and other regulatory standards. The levels of complexity, integration, and application are examined to bring about a streamlined system that is effective, efficient, and not burdened by superfluous documentation.

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MasterControl's Document Workshop Course Overview

Poor or incomplete documentation accounts for more noncompliances during audits than virtually anything else. However, it is often difficult to know just how much documentation is enough. Although FDA regulations and international standards require regulated organizations to establish compliant documentation processes, few, if any, concrete guidelines are given on how to create and implement a compliant documentation system. In just two days, the document workshop will teach participants the good documentation practices they need to dramatically improve their organization's efficiency and effectiveness. Topics to be covered include:

Quality Systems - Participants will learn how to plan and devise the appropriate system for a sound structure and a thorough application of principles and compliance in a risk-based approach quality plan.

Formats of Documentation - Document workshop participants will review best-practice applications for conveying the meaning and nature of operations within the QMS.

Continual Improvement - Participants will learn to incorporate an effective venue for improvement actions based on good process evaluation and effective decision making.

Implementation and Effectiveness Checking - Participants will learn how to verify, validate, implement, monitor, and confirm the success of the QMS system through comprehensive and targeted auditing and analytics.

Change Control - Document workshop participants will gain an understanding of the critical aspects of change in the common cause and effect relationship to avoid reactive and costly actions.

The document workshop provides quality professionals with the skills and tools they need to eliminate the following common documentation problems:

Death by documentation, i.e., the excessive supply of unnecessary information

A poor audit trail of documents that frustrates auditors and leads to findings

"Stovepipe" procedures that hinder good communication

Cumbersome processes that are not in compliance with global regulatory compliance standards

Lack of continuity between process activities due to poor quality planning

Poorly developed process documentation that creates ambiguity in work activities

The document workshop is taught using a blended approach of classroom and real-life application. This "how-to" approach significantly increases knowledge retention and allows participants to apply the skills as they learn in a dynamic setting. Click here to review the workshop agenda.

Who Should Attend the Document Workshop?

The document workshop is appropriate for individuals who are regularly involved in preparing plans, procedures, and instructions as part of a documented management system, especially those responsible for document maintenance and improvement.

The on-site document workshop is one of five quality management workshops offered by MasterControl to help quality professional gain the skills they need to stay current and compliant in the workplace. Additional workshops are offered in audit, risk, CAPA, and supplier management. All workshops are delivered on-site at the customer's facility and can be customized to address specific industry compliance requirements. Class size is limited to 14 participants. Click on the links below for details on the additional workshops:

Risk Workshop

Audit Workshop

CAPA Workshop

Supplier Workshop

For More Information on MasterControl's Document Workshops

For more information about the document workshop, or any of our quality management workshops, contact the MasterControl Quality and Compliance Consulting Team or call 866.747.8767 today.

The QMS Provider for the FDA

MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.

Software Magazine ranks MasterControl 369 on its 2014 Software 500 list, a listing of the world's largest software and services providers. Now in its 32nd year, the Software 500 is a revenue-based ranking of vendor viability. Learn More